Glidewell Dental
Essential Functions
:
Leads the ongoing implementation of Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices. Responsible for the administration of the QMS software. Conducts investigations and provides corrective and preventive actions based on analysis and review. Provides and implements effective solutions that will drive continuous and measurable improvements. Integrates ISO 14971, ISO 13485, risk management and IEC 62366 usability engineering activities with Glidewell/Prismatik processes. Fosters and maintains organizational compliance to the quality system including ongoing training and education on software QMS and Prismatik framework. Provides CAPA, complaints, audit and overall QMS support in regards to software. Performs other related duties and projects as business needs require at direction of management. Minimum Qualifications:
Bacheloru2019s degree in Engineering, Biomedical, or related technical field or equivalent practical experience. Minimum of eight (8) years of related experience in the FDA QSR/ISO 13485 medical device industry. Advance knowledge with development and test requirements with recognized standards (ISO 13485). Demonstrated knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the Prismatik practices and the QMS. Pay range: $85,000.00 - $130,000.00/yr. Exact compensation may vary based on skills and experience. #J-18808-Ljbffr
:
Leads the ongoing implementation of Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices. Responsible for the administration of the QMS software. Conducts investigations and provides corrective and preventive actions based on analysis and review. Provides and implements effective solutions that will drive continuous and measurable improvements. Integrates ISO 14971, ISO 13485, risk management and IEC 62366 usability engineering activities with Glidewell/Prismatik processes. Fosters and maintains organizational compliance to the quality system including ongoing training and education on software QMS and Prismatik framework. Provides CAPA, complaints, audit and overall QMS support in regards to software. Performs other related duties and projects as business needs require at direction of management. Minimum Qualifications:
Bacheloru2019s degree in Engineering, Biomedical, or related technical field or equivalent practical experience. Minimum of eight (8) years of related experience in the FDA QSR/ISO 13485 medical device industry. Advance knowledge with development and test requirements with recognized standards (ISO 13485). Demonstrated knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the Prismatik practices and the QMS. Pay range: $85,000.00 - $130,000.00/yr. Exact compensation may vary based on skills and experience. #J-18808-Ljbffr